BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3120749 · Received May 20, 2013

    Report

    Report Number
    1226181-2013-00233
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 25, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LAO
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOTREXATE IS A USER DEFINED METHOD (UMD). FOR UDMS, THE DIMENSION VISTA SYSTEM OPERATOR'S GUIDE STATES: "THE CUSTOMER ASSUMES ALL RESPONSIBILITY FOR SELECTING THE PROPER REAGENTS AND FOR ENTERING THE PROPER TEST PARAMETERS, USING PROPER TEST PROTOCOLS, DETERMINING THE CORRECTNESS OF TEST RESULTS AND RESOLVING ANY ASSOCIATED ERRORS OR OMISSIONS." THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, LOW METHOTREXATE RESULTS WERE OBTAINED FOR ONE PATIENT ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE PATIENT WAS REDRAWN AND THE NEW SAMPLE WAS TESTED ON THE SAME INSTRUMENT AND RESULTED HIGHER. THE INITIAL AND REDRAW SAMPLES WERE THEN TESTED ON AN ALTERNATE INSTRUMENT, AND THE REDRAW SAMPLE RESULTS ALIGNED WITH THE REDRAW RESULTS FROM THE DIMENSION VISTA 1500. THE INITIAL SAMPLE RESULTED HIGHER ON THE ALTERNATE INSTRUMENT THAN FROM THE DIMENSION VISTA 1500. IT IS UNKNOWN IF THE RERUN RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW METHOTREXATE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222567 DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM LAO SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1